(399 days)
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.
The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader. The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician. The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor). The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: ID-Cap System
Predicate Device: Ingestion Event Marker (IEM) Data recorder (Patch) (K150494 - Proteus Digital Health Feedback Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" as a separate, quantitative table. Instead, it presents a comparison with a predicate device and implicitly sets performance targets based on the predicate's performance and the device's intended function. The "Comments" column in Table 5 functions as a statement of equivalence or acceptable difference.
Here's a re-organized table focusing on the performance metrics presented, drawing implications of acceptance from the comparison:
| Metric | Acceptance Criteria (Implied from Predicate/Safety) | Reported ID-Cap System Performance |
|---|---|---|
| Clinical Performance | ||
| Positive Detection Accuracy (PDA) | Comparable to predicate (97.2% with 95% CI) to ensure reliable detection of ingestion events. | 95.0% (Similar PDA to predicate) |
| Negative Detection Accuracy (NDA) | 100% (95% CI) as demonstrated by predicate, indicating no false positive ingestion events. | 100% (95% CI) (Similar NDA to predicate) |
| Unanticipated Adverse Device Effects | None, demonstrating device safety. | None (Similar to predicate) |
| Severe Adverse Events (related to System) | None, demonstrating device safety. | None (Similar to predicate) |
| Discontinuations due to AEs | Lower or equal to predicate (2.8% due to skin irritation), ideally zero for non-skin contact device. | None (Improved over predicate, as skin irritation risk is mitigated by design) |
| Ingestible Sensor AEs | Comparable incidence and severity to predicate (5.7% of subjects, 0% of ingestions, mostly mild) to ensure acceptable safety profile. | 10.2% of subjects (100% mild in severity) in pooled safety analysis; Incidence of at least one related AE is 0.6% of ingestions. (Similar w.r.t. incidence and severity of AEs reported for device use) |
| Data Recorder AEs | Lower or equal to predicate (17.7% of subjects reporting skin irritation), ideally none since it's not a skin-contact device. | None (Improved over predicate, as skin irritation risk is mitigated by design) |
| Proper Excretion of ID-Tags | All ID-Tags should be excreted without retention. | Confirmed by post-ingestion X-rays showing non-retention. |
| Technological Characteristics (Non-Clinical) | ||
| Time to Detect | Comparable to predicate's activation time, allowing for the dissolution of the capsule. Predicate: 1.0 minute mean. | 6.4 minutes (mean) for ID-Tag encapsulated in ID-Capsule in direct observation clinical study. (Longer than predicate due to capsule dissolution, but acceptable given longer signal duration). |
| Duration of Detected Signal | Sufficiently long to ensure reliable detection. Predicate: 7.29 minutes mean. | 27.9 minutes (mean) from first detection in direct observation clinical study. (Longer than predicate). |
| Biocompatibility | All patient-contacting materials (ingestible sensor, reader where applicable) must be biocompatible and non-toxic per ISO 10993 standards and risk assessment. | Tested per ISO 10993-1, including cytotoxicity, sensitization, irritation, pyrogenicity, implantation, acute/subacute systemic toxicity, and chemical characterization. All found biocompatible and non-toxic. |
| Electrical Safety | Compliance with IEC 60601-1 standards. | Tested to IEC 60601-1:2005 (3rd Edition) & IEC 60601-1-11:2015. Passed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standards. | Tested to IEC 60601-1-2:2014 (4th Edition and home use levels) & JIS T 0601-1-2 (12th Edition 2012). Passed. |
| Wireless Coexistence | Acceptable performance in wireless coexistence scenarios. | Tested to ANSI C63.27 2017 Wireless Coexistence. Acceptable. |
| Spectrum Compatibility & RF Safety | Compliance with relevant regulations (FCC and Industry Canada). | FCC and Industry Canada Grant of Authorization received. Acceptable. |
| Mechanical Performance | Passed impact resistance tests and other mechanical strength requirements. | Tested per IEC 60601-1:2005 (3rd Edition) & IEC 60601-1-11:2015, and other applicable tests. Acceptable. |
| Shelf-Life | Verified shelf-life for capsules and acceptable aging performance for Readers. | Shelf-life testing performed for ID-Capsules, and shelf-life/aging analysis performed for Readers. Acceptable. |
| Human Factors & Usability | Demonstrate ease of use and safety for intended user groups (patients and clinicians). | Summative usability validation study conducted with two user groups (patient and clinician). Results supported design, function, appropriate use, and performance. Acceptable. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not explicitly stated as a single number for a "test set." The clinical studies included participants (18 – 79 years old, mean 41.9 years, stratified by gender and BMI). The specific number of ingestions or unique patients contributing to the PDA/NDA calculations is not provided, only the resulting percentages.
- Data Provenance: Retrospective or prospective is not explicitly stated. However, the mention of "clinical studies" and "direct observation clinical study" implies prospective clinical data collection. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. The ground truth for this device (ingestion detection) appears to be established by direct observation in clinical settings, rather than expert review of independent data (like image annotations by radiologists). The device's function is to detect an event that is directly observable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device. The "ground truth" for ingestion is likely established by direct clinician observation or participant logging combined with the device's own detection, not by independent adjudication of outputs from a black-box system.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
Not applicable. This device is an ingestible event marker, not an AI-powered diagnostic imaging tool that assists human readers. Its primary function is automated detection, not interpretation requiring human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the core performance metrics (Positive Detection Accuracy, Negative Detection Accuracy, Time to Detect, Duration of Detected Signal) are presented as standalone algorithm performance (the ID-Cap System's ability to detect ingestion events). The device is designed for "unattended data collection," indicating a standalone operational mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for ingestion events was established through direct observation in clinical studies. For example, the "Time to Detect" and "Duration of Detected Signal" metrics were derived from a "direct observation clinical study." Proper excretion was confirmed by post-ingestion X-rays.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "performance testing" section refers to clinical studies and bench testing, not an ML model's training data.
9. How the ground truth for the training set was established
Not applicable, as this is not a machine learning model. Performance validation was done through clinical studies and extensive engineering/bench testing against established standards and internal requirements.
§ 880.6305 Ingestible event marker.
(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.